Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-04-27 - 2007-06-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Chemical name: N-(3(5)-Methyl-1 H-pyrazol-1 -yl-methyl)-acetamid
Code of the sponsor: P 70/05 Formula: C7H11N3O
Description: white, amorphous solid
Purity: > 99 % (HPLC and NMR)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
The study room and cages were cleaned and disinfected before the animals arrived. During the study, the room and cages were cleaned at regular intervals. From the randomisation until sacrificing a single animal was housed in a Makrolon® Type 3 cage.
ALTROMIN 1324, pelleted standard diet (ALTROMIN, D-32791 Lage/Lippe) Batch: 161007/1025
With the exception of overnight fasting before oral administration and until 3 hours after administration food was available ad libitum.
Environment: air conditioned,
temperature: 22 - 25 °C,
relative humidity: 33 - 70 %, with a shortly rising on 75 %
artificial light was set to give a cycle of 12 hours light and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m.
The diet is delivered periodically with an accompanying certificate of analysis giving details of nutritional composition and levels of specified contaminants (heavy metals, aflatoxins and pesticides).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Tylose MH 1000 in deionised water
Details on oral exposure:
Route of administration: orally, by gavage; using a metal catheter and disposable plastic syringes.
Rationale: The acute toxicity is to determine at first by the oral administration.
Doses:
2000 mg/kg body weight (b.w.)
No. of animals per sex per dose:
6 female animals
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the course of investigation.
Clinical signs:
Only on the day of administration some clinical signs (squatting position, rough hair coat, impaired general condition) were observed in the animals of the second step of the study (animals 4 - 6).
Body weight:
The body weight gain of the animals was not affected by the administration of the test item.
Gross pathology:
No substance dependent pathological finding was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity of N-(3(5)-Methyl-lH-pyrazol-l-yl-methyI)-acetamid (P 70/05) was tested in 6 female Charles River Wistar rats according toOECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).
The test item was administered at the single dose of2000mg/kg body weight (Limit test) by gavage.
All animals were examined for mortality, clinical signs and body weight gain. The pathological alterations of organs were examined at the end of a 14-day observation period.
None of the animals died after a single oral administration of 2000 mg/kg b.w. N-(3(5)-Methyl-1 H-pyrazol-1 -yl-methyl)~acetamid (P 70/05).
The LD50 p.o. rat is > 2000 mg/kg b.w.
Apart from some clinical signs on the day of administration which are signs of an impaired general condition no clinical symptoms were observed during the further course of investigation.
The body weight gain of the animals was not affected. No substance dependent pathological finding was observed.
Executive summary:

The acute oral toxicity of N-(3(5)-Methyl-lH-pyrazol-l-yl-methyI)-acetamid (P 70/05) was tested in 6 female Charles River Wistar rats according toOECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

The test item was administered at the single dose of2000mg/kg body weight (Limit test) by gavage.

All animals were examined for mortality, clinical signs and body weight gain. The pathological alterations of organs were examined at the end of a 14-day observation period.

None of the animals died after a single oral administration of 2000 mg/kg b.w. N-(3(5)-Methyl-1 H-pyrazol-1 -yl-methyl)-acetamid (P 70/05).

The LD50 p.o. rat is > 2000 mg/kg b.w.

Apart from some clinical signs on the day of administration which are signs of an impaired general condition no clinical symptoms were observed during the further course of investigation.

The body weight gain of the animals was not affected. No substance dependent pathological finding was observed.